Kornimate/medical-research-clean huggingface dataset:
citalopram versus citalopram plus pindolol in major depressive disorder

Conditions: Major Depressive Disorder; Antidepressant Treatment Response

Summary: the purpose of this study is to examine whether the speed of the clinical antidepressant action of citalopram can be accelerated by administering double doses of pindolol (15 mg/day, tid) which presumably should lead to increased 5-ht1a autoreceptor occupancy.

design, settings, and participants. a randomised, double-blind, placebo-controlled trial with mdd patients allocated to two treatment arms: citalopram + pindolol versus citalopram + placebo. participants: outpatients with a depressive episode (dsm-iv criteria) were selected from a general hospital.

Eligibility criteria:
inclusion criteria: * patients with a depressive episode * hdrs score \> 18 * written informed consent exclusion criteria: * suicidal risk \> 3 * severe organic illness * other psychotropic drugs

Keywords: major depressive disorder, citalopram, pindolol, hdrs
a pilot study comparing the analgesic efficacy of iv ibuprofen and iv ketorolac

Conditions: Chronic Pelvic Pain

Summary: the primary objective of this study is to compare the efficacy of a single dose of intravenous ibuprofen compared to a single dose of ketorolac for the treatment of postoperative pain as measured by patient pain intensity (visual analog scale, vas).

the primary objective of this study is to compare the efficacy of a single dose of intravenous ibuprofen compared to a single dose of ketorolac for the treatment of postoperative pain as measured by patient pain intensity (visual analog scale, vas). the secondary objectives of this study are: * to compare amount of and time to rescue medication in the postoperative period between iv ibuprofen and iv ketorolac treatment groups. * to compare time to mobility in the postoperative period between iv ibuprofen and iv ketorolac treatment groups. * to compare time to discharge in the postoperative period between iv ibuprofen and iv ketorolac treatment groups. * to compare the incidence of adverse events between iv ibuprofen and iv ketorolac treatment groups.

Eligibility criteria:
inclusion criteria: * patients with a preoperative diagnosis which is inclusive of chronic pelvic pain scheduled for laparoscopic surgery exclusion criteria: * inadequate iv access. * history of allergy or hypersensitivity to any component of ivib,ketorolac, aspirin (or aspirin related products), nsaids, or cox-2 inhibitors. * less than 18 years of age or greater than 65 years of age. * use of analgesics, including nsaids, less than 12 hours prior to surgery. * patients with active, clinically significant anemia. * history or evidence of asthma or heart failure. * pregnant. * inability to understand the requirements of the study, be willing to provide written informed consent (as evidenced by signature on an informed consent document approved by an institutional review board \[irb\]), and agree to abide by the study restrictions and to return for the required assessments. * refusal to provide written authorization for use and disclosure of protected health information. * patients with a history of chronic pain conditions or syndromes excluding patients with chronic pelvic pain. * patients with known osa

Keywords: ketorolac caldolor chronic pelvic pain
utility of some novel biomarkers of patients with chronic heart failure

Conditions: Heart Failure

Summary: clinical and economic study of some new biomarkers in chronic heart failure.

the study aimed at evaluation of the clinical and economic value of some new biomarkers in chronic heart failure.

Eligibility criteria:
inclusion criteria: * nyha-class ii-iv exclusion criteria: * liver or renal dysfunction. --dm
study of the effects of chemotherapy on memory and other mental functions in women with breast cancer

Conditions: Breast Cancer

Summary: many breast cancer patients treated with chemotherapy complain of problems with concentration and memory. this has been referred to as chemo fog. the current study is investigating this phenomenon by measuring mental function of breast cancer patients prior to and after exposure to chemotherapy, and by comparing mental function in those patients who receive chemotherapy and those who do not.

many breast cancer patients treated with chemotherapy complain of problems with concentration and memory. this has been referred to as chemo fog. the current study will investigate this phenomenon by measuring neuropsychological functioning in early stage breast cancer patients prior to and after exposure to chemotherapy, and by comparing change in cognitive function in patients who receive chemotherapy to similar breast cancer patients receiving hormonal therapy only.

Eligibility criteria:
inclusion criteria: * stage i or ii breast cancer; woman; 50-65 years old; post-menopausal exclusion criteria: * history of previous cancer or chemotherapy; significant neurological or psychiatric history

Keywords: breast cancer chemotherapy hormonal therapy cognitive function chemo fog
gallium-68 psma-11 pet imaging in prostate cancer patients

Conditions: Prostate Cancer

Summary: the investigators are imaging patients with prostate cancer using a new positron emission tomography (pet) imaging agent (ga-68-psma-11) in order to evaluate its ability to detect prostate cancer.

patients will be imaged using ga-68 labeled psma-11 pet to determine if there is presence of metastatic disease. prostate specific membrane antigen (psma) is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protocol. pet imaging will begin 50-100 minutes after injection, but may be possible in certain circumstances for imaging to be delayed due to patient workflow or equipment issues primary objective: sensitivity on a per-patient and per-region-basis (table 1) of 68ga-psma-11 pet for detection of tumor location confirmed by histopathology/biopsy, clinical and conventional imaging follow-up.

Eligibility criteria:
inclusion criteria: 1. male, age \>= 18. 2. histopathologically proven prostate adenocarcinoma. 3. concern for metastatic disease in one of the following settings: 1. initial staging with intermediate to high risk prostate cancer. 2. biochemical recurrence after initial therapy. 4. ability to understand a written informed consent document, and the willingness to sign it. exclusion criteria: 1. patient unlikely to comply with study procedures, restrictions and requirements and judged by the investigator to be unsuitable for study participation.
instrumental sealing of arterial puncture site closure device versus manual compression trial

Conditions: Coronary Artery Disease

Summary: are novel vascular closure devices noninferior to manual compression regarding access site complications after coronary angiography?

vascular closure devices have been shown to be safe and effective in reducing the time to hemostasis and immobilization when compared to manual compression following coronary angiography. this effect is beneficial in patients presenting with chronic back pain, prostate enlargement, mental impairment or other disorders that preclude prolonged bed rest. however, adequately powered large scale randomized trials with vascular closure devices remain a gap in the scientific literature. this trial compares, in a randomised design two novel vascular closure devices (femoseal \& exoseal) versus manual compression after coronary angiography. this study is aimed to investigate if novel vascular closure devices are noninferior to manual compression regarding access site complications.

Eligibility criteria:
inclusion criteria: * patient between 18 and 85 years of age * patients undergoing femoral access coronary angiography * access only with 6 f sheath * patient must be competent for providing informed written consent exclusion criteria: * peripheral arterial occlusive disease * prior peripheral artery surgery * percutaneous coronary intervention * femoral access device closure in last 30 days * scheduled coronary angiography/intervention within 90 days * critical limb ischemic * uncontrolled hypertension \>220/110 mmhg * coagulopathy (bleeding disorder) * local infection * common femoral artery lumen diameter \< 5 mm * allergy to absorbable suture * autoimmune disease * pregnancy

Keywords: closure device coronary angiography
absolute bioavailability of a single, fixed subcutaneous dose of aducanumab in healthy participants

Conditions: Alzheimer's Disease

Summary: the primary objectives of this study are to evaluate the absolute bioavailability of a single, fixed sub-cutaneous (sc) dose of aducanumab compared with a single, weight-based intra-venous (iv) dose in healthy participants and to characterize the pharmacokinetics (pk) profile of aducanumab. the secondary objectives are to evaluate the safety and tolerability of aducanumab administered via sc and iv routes in healthy participants and to characterize additional pk parameters of a single, fixed sc dose of aducanumab and a weight-based iv dose in healthy participants.


Eligibility criteria:
key inclusion criteria: * a minimum weight of 45 kg, inclusive, at day -1. * all women of childbearing potential and all men must practice highly effective contraception during the study and be willing and able to continue contraception for 24 weeks after study treatment dosing (day 1). * must be in good health (as determined by the investigator) based on the medical history and screening evaluations. key exclusion criteria: * mini mental state examination (mmse) score of \<27 at screening. * history of any clinically significant cardiac, endocrinologic, hematologic, hepatic, gastrointestinal, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, or renal disease, or other major disease, as determined by the investigator. * history of severe allergic or anaphylactic reactions that in the opinion of the investigator is likely to be exacerbated by any component of the study treatment. * history of malignant disease, including solid tumors and hematologic malignancies (with the exception of basal cell and squamous cell carcinomas of the skin that have been completely excised prior to study entry). * history of, or positive test result at screening for, human immunodeficiency virus (hiv). * positive test result at screening for hepatitis c virus antibody (hcvab). * positive test result at screening for hepatitis b virus (defined as positive for both, hepatitis b surface antigen \[hbsag\] and hepatitis b core antibody \[hbcab\]). * chronic, recurrent, or serious infection (e.g., pneumonia, septicemia) as determined by the investigator, within 90 days prior to day -1. note: other protocol defined inclusion/exclusion criteria may apply
articaine versus lidocaine buccal infiltration

Conditions: Pain

Summary: assess the effect of articaine versus lidocaine in only buccal infiltration of local anethesia in lower anterior teeth


Eligibility criteria:
inclusion criteria: * medically stable * 18years or older * patient with bilateral lower anterior teeth requiring non surgical removal exclusion criteria: * grade 3 mobility * neurological disease * allergy to anethesia

Keywords: buccal infiltration lidocaine articaine
vertebral bone marrow clot for spinal surgery

Conditions: Degenerative Spine Diseases

Summary: spinal fusion (sf) is a common orthopedic procedure to treat spinal diseases. apart from fixation systems, the procedure requires bone grafting to further improve sf. cell-based therapies as vertebral bone marrow aspirate (vbma) with bone allograft were developed as alternative to bone autograft in sf. however, vbma use is limited by the lack of a standardized procedure, of a structural texture and by the possibility of diffusion away from the implant site. recently, the potential use of a new formulation of vbma, named vbma clot, has been described. the project aims at evaluating the clinical evidence and the biological features of vbma clot associated to bone allograft for sf surgery, considering age and gender related differences. a randomized controlled trial will prove the efficacy of the treatment and advanced preclinical studies will improve the knowledge on vbma clot regenerative and anti-inflammatory properties, exploring for the first time its antibacterial characteristics.

to evaluate the efficacy of autologous vbma clot in sf procedures in patients with degenerative spine diseases, a randomized controlled trial (rct) will be carried out. the study will compare patients treated with autologous vbma clot associated to bone allograft chips versus bone allograft chips alone (standard treatment), also evaluating whether patient age and gender are associated with differences in the clinical outcomes.

Eligibility criteria:
inclusion criteria: * degenerative spinal disorders (based radiological diagnosis) * posterior spinal stabilization ≤ 5 levels * age between 18-80 years at the time of surgery exclusion criteria: * hiv * hbv * hcv * coagulations disorders * pregnant or breast-feeding women * cancer * infections * previous spinal surgery * radio- chemotherapy * myeloproliferative disease * chronic steroid medication, thyroxin, immunodepression

Keywords: spine spinal fusion degenerative diseases vertebral bone marrow clot
hand rehabilitation using botulinum toxin and functional electrical stimulation-pilot study

Conditions: Stroke; Spastic Hemiparesis; Spasticity as Sequela of Stroke

Summary: the investigator tried to find out possibility of functional improvement using botulinum toxin injection targeting finger flexor spasticity with functional electrical stimulation among chronic stroke patients who did not show any improvement in hand function.


Eligibility criteria:
inclusion criteria: * age over 18 years * hemiplegic upper limb spasticity secondary to a unilateral ischemic or hemorrhagic stroke * fingers and wrist flexor spasticity graded at least 1+ on the modified ashworth scale * at least 6 months since stroke exclusion criteria: * fixed contracture * previous treatment of the upper limb spasticity with neurolytic or surgical procedure * treatment with botulinum toxin type a in the previous 4 months * any active device implant * any neurological disorder, other than stroke causing motor deficits or spasticity * inability to attend to and/or to cooperate with all outcome measure-related task secondary to cognitive impairment or aphasia * pregnancy, planned pregnancy, or lactation * contraindication to botulinum toxin type a

Keywords: stroke hand botulinum toxin functional electrical stimulation
a study evaluating the safety and efficacy of ibi188 in combination with aza in subjects with newly diagnosed mds

Conditions: MDS

Summary: this is an open-label, phase 1b study to evaluate the safety, tolerability and preliminary efficacy of ibi188 in combination with azacitidine in newly diagnosed higher risk mds patients.


Eligibility criteria:
main inclusion criteria: 1. newly diagnosed mds subjects with higher risk. 2. age ≥ 18 years old. 3. eastern cooperative oncology group score of 0-2. 4. adequate organ function. 5. subjects should take effective contraceptive measures. 6. must sign the informed consent form (icf), and be able to follow all study procedures. main exclusion criteria: 1. subject who has transformed from mds to aml. 2. mds subjects with lower risk. 3. subjects who have received chemotherapy. 4. history of chronic hemolytic anemia 5. prior exposure to any anti-cd47 or anti-sirpα agents. 6. subjects participating in another interventional clinical study.

Keywords: mds
nebulization versus spray-as-you-go airway topical anesthesia using dexmedetomidine and lidocaine mixture during awake flexible fiberoptic intubation in temporomandibular ankylosis

Conditions: Nebulization; Spray-as-You-Go; Dexmedetomidine; Lidocaine; Temporomandibular Ankylosis

Summary: the aim of this study is to compare the efficacy of airway topical anesthesia with nebulization to the spray-as-you-go technique using dexmedetomidine and lidocaine mixture to achieve upper airway anesthesia in tmj ankylosis patients.

awake fiber-optic intubation (afoi) has become the accepted gold standard technique for management of recognized difficult airway as the larynx remains in a posterior position and the patient is able to protect the airway from soiling and can maintain the airway patency as well as spontaneous breathing efforts. awake intubation requires that the patient remains calm and cooperative and is provided with sufficient anxiolysis, analgesia, and topical anesthesia without compromising the airway. gag reflex, cough, and laryngospasm can be upsetting during the process. awake patients never permit airway instrumentation without airway anesthesia. therefore, effective airway anesthesia is required for airway instrumentation and patient comfort. for awake intubation, topical airway anesthesia can be provided either by using fiberoptic bronchoscope (fob) to apply local anaesethic to the airway by a "spray-as-you-go" technique or nebulizing the patient for about 10-15 min.

Eligibility criteria:
inclusion criteria: * age from 21to 65 years. * both sexes. * american society of anesthesiologists (asa) physical status i or ii and scheduled for elective surgery requiring general anesthesia , and known to have temporomandibular joint ankylosis and expected to be difficult intubation patient due to restriction of jaw mobility and limited mouth opening less than 2 fingers. exclusion criteria: * history of allergy to dexmedetomidine or lidocaine. * history of drug abuse. * concomitant use of medications which may exaggerate the heart rate (hr) response of -dexmedetomidine (e.g. digoxin or β-adrenergic antagonists), hr \<50 beats/min, systolic blood pressure (sbp) \<90 mmhg. * pregnancy. * morbid obesity( bmi more than 35). * patients on anticoagulants, nasal trauma, deformity or polyp, csf rhinorrhea, fracture base skull. * cardiac and/or respiratory disease, reactive airway disease, hepatic or renal disorders.
natural killer (nk) cell therapy targeting cd33 in acute myeloid leukemia

Conditions: AML, Adult

Summary: this is an open-label, phase i study of qn-023a (allogeneic car-nk cells targeting cd33) in relapsed/refractory acute myeloid leukemia (aml). the clinical study is to evaluate the safety, tolerability and preliminary efficacy of qn-023a in patients with relapsed/refractory aml,where a "3+3" enrollment schema will be utilized at dose escalation stage. up to 19 patients will be enrolled.


Eligibility criteria:
key inclusion criteria: * provision of signed and dated informed consent form (icf) * ≥18 years old * diagnosis of r/r aml * subjects with cd33 positive leukemia cells * eastern cooperative oncology group (ecog) performance status ≤1 * adequate organ function as defined in the protocol * donor specific antibody (dsa) to qn-023a: mfi \<= 2000 key exclusion criteria: * allergic to drug used in this study * accept other anti-tumor drugs/therapies within certain time of day 0 (first qn-023a dose infusion), time window and drug defined in the protocol. * received systemic immunosuppressive therapy within 7 days of day 0, or likely to require systemic immunosuppressive therapy * acute promyelocytic leukemia (apl) * central nervous system leukemia. * uncontrolled, active clinically significant infection * clinically significant cardiovascular disease as defined in the protocol * known hiv infection, active hepatitis b (hbv) or hepatitis c (hcv) infection * history of central nervous system (cns) disease such as stroke, epilepsy. * females are pregnant or lactating * investigator-assessed presence of any medical or social issues that are likely to interfere with study conduct or may cause increased risk to subject
the effect of progressive relaxation and breathing exercise on sleep quality and exercise self-efficacy in patients with copd

Conditions: COPD Asthma

Summary: aim: this study was conducted to determine the effect of progressive muscle relaxation and breathing exercise on sleep quality and exercise self-efficacy in chronic obstructive pulmonary patients. methods: this study was conducted as a randomized controlled experimental study. the study was conducted with 64 chronic obstructive pulmonary patients, where 36 of them were in the intervention group and 34 in the control group. data of the study were collected using the descriptive information form, the pittsburgh sleep quality index, and the exercise self-regulatory efficacy scale (ex-sres) for patients with copd. results: when the total scores pertaining to the sleep quality index and exercise self-efficacy of the individuals in the intervention and control groups were compared, it was found that there were statistically significant differences in the intervention group compared to the control group (p \< 0.05). keywords: exercise self-regulatory efficacy, sleep quality in patients with copd, pge along with breathing exercises, pulmonary rehabilitation


Eligibility criteria:
inclusion criteria: * were to be 18 years of age or older * not using sleeping pills * verbally stating that they have moderate and severe sleep disorders. exclusion criteria: * having any lung disease other than copd * having cardiological problems (heart failure, uncontrollable hypertension, history of angina and myocardial infarction, heart valve problems), psychotic disorder, * inability to communicate verbally and having hearing problems.

Keywords: exercise self-regulatory efficacy, sleep quality pge with breathing exercises pulmonary rehabilitation
predictive value of flow mri in normal pressure hydrocephalus surgery

Conditions: Normal Pressure Hydrocephalus

Summary: the idea is to assess the predictive value of flow magnetic resonance imaging (flow mri) for patient suffering normal pressure hydrocephalus (nph) planned for surgery. by now, the depletive lumbar puncture is the best test assessing the efficacy of a forthcoming surgery. the idea is to demonstrate that flow mri can be as effective as lumbar puncture in term of predictive value of surgery response. in that way, cerebrospinal fluid (csf) dynamics are evaluated by a single non invasive examination. csf flow is measured at the sylvius' aqueduct, cervical, arachnoid space and 4th ventricle levels.


Eligibility criteria:
inclusion criteria: * age: over 20 years * diagnostic of normal pressure hydrocephalus * ventricular dilation visible on radiological examination * patients gave their written informed consent exclusion criteria: * age: less than 20 years * mri contra-indication * pregnancy * lumbar puncture within 48 hours before mri * cardiac arrhythmia * cerebral/lacunar stroke

Keywords: normal pressure hydrocephalus flow mri dementia cerebrospinal fluid shunt